Outline

Background: Serious rare haematotoxicity may significantly alter the risk/benefit ratio of a drug, but it is often only recognized during postmarketing surveillance. Active hospital-based surveillance of serious, rare blood dyscrasias within the Berlin Case-Control Surveillance Study (FAKOS) is a method for new signal generation of drug haematotoxicity.

Objective: To quantify the number of new safety signals of serious drug-induced haematotoxicity generated within the FAKOS Study between October 2000 and Sep 2006.

Material and methods: 467 patients (age ≥18) with first occurrence of a serious rare blood dyscrasia were identified in 54 hospitals and 15 haematological practices in Berlin. WHO causality assessment was performed to identify possible ADRs. For possible ADRs, the German Summary of Product Characteristics (SPC) of the respective drug was screened whether it already contained information on the specific blood dyscrasia (III. Quartal 2006). The information was classified as “no previous information” (= new safety signal), “unspecific information” and “specific information”.

Results: For 38 (20%) out of 194 drugs identified as possible causes of rare blood dyscrasias, there was no previous information available in the German SPC.

Conclusion: FAKOS is an effective instrument for new signal generation during postmarketing surveillance.